Mandibular advancement and retraction via bone anchoring devices

ABSTRACT

Systems, methods, devices and apparatus for mandibular advancement or retraction via bone anchoring devices are described herein. In various aspects, an apparatus for treating a patient via mandibular advancement or retraction comprises a plurality of anchoring devices positioned in the patient&#39;s intraoral cavity. Each of the plurality of anchoring devices can be positioned in bone of the patient&#39;s upper jaw or bone of the patient&#39;s lower jaw. One or more connecting structures can be removably coupled to and extend between the plurality of anchoring devices in order to displace the lower jaw anteriorly or posteriorly relative to the upper jaw.

CROSS-REFERENCE

This application is a continuation of U.S. application Ser. No.14/992,299, filed Jan. 11, 2016, which claims the benefit of U.S.Provisional Application No. 62/161,809, filed May 14, 2015, and U.S.Provisional Application No. 62/103,015, filed Jan. 13, 2015, thedisclosures of each of which are incorporated herein by reference intheir entirety.

BACKGROUND

Obstructive sleep apnea (OSA) is a serious medical conditioncharacterized by complete or partial blockage of the upper airway duringsleep. The obstruction may be caused by relaxation of soft tissues andmuscles in or around the throat (e.g., the soft palate, back of thetongue, tonsils, uvula, and pharynx) during sleep. OSA episodes mayoccur multiple times per night, thus disrupting the patient's sleepcycle. Suffers of chronic OSA may experience sleep deprivation,excessive daytime sleepiness, chronic fatigue, headaches, snoring, andhypoxia.

The use of mandibular advancement devices (also referred to asmandibular splints or mandibular advancement splints) has been proposedto treat OSA. A mandibular advancement device is an oral appliance wornin the mouth over the teeth of the upper and/or lower jaws. The devicetreats sleep apnea by advancing the lower jaw in an anterior directionrelative to the upper jaw. This advancement tightens the tissues of theupper airway, thus inhibiting airway obstruction during sleep.

In some instances, however, existing mandibular advancement devices fortreating OSA may produce undesirable side effects, such as toothrepositioning, jaw discomfort, and muscle strain. For these reasons, itwould be desirable to provide alternative and improved methods andapparatus for treating obstructive sleep apnea and snoring. Inparticular, it would be desirable to provide alternative and improvedmethods and apparatus which provide mandibular advancement whilereducing or eliminating tooth displacement.

SUMMARY

Systems, methods, devices, and apparatus described herein can be used totreat a patient via mandibular advancement and/or retraction withreduced unintentional tooth repositioning. An apparatus for treating apatient with mandibular advancement and/or retraction may comprise aplurality of anchoring devices for positioning in bone of the patient'sintraoral cavity, and one or more connecting structures. The one or moreconnecting structures can be removably couplable to the anchoringdevices so as to displace the lower jaw anteriorly or posteriorlyrelative to the upper jaw with reduced unintentional toothrepositioning. The anchoring devices can placeable in the bone of theupper jaw, lower jaw, or both jaws. The connecting structures couplableto bone anchoring devices can provide forces to the jaws and withdecreased forces to the teeth, in order to reduce unintentional toothrepositioning. The connecting structures and anchoring devices asdescribed herein can produce mandibular advancement and/or retractionwhile reducing unwanted jaw movements such as vertical displacement ofthe jaws. The one or more connecting structures can improve control overthe patient's jaw configuration during treatment and reduce undesirableside effects such as bruxing of the teeth (teeth clenching or grinding).The apparatus described herein can include at least one connectingstructure that provides for the application of anterior and/or posteriorforces to the jaws to produce the desired mandibular advancement and/orretraction while inhibiting unwanted jaw movements such as verticalmovements (e.g., jaw opening and/or closing movements). For example, theconnecting structure can be a stiff or elastic structure capable ofsupporting bending and/or shear loads in order to apply anterior and/orposterior forces independently from or without applying undesirablevertical forces. The mandibular advancement and/or retraction approachesprovided herein can be useful for treating a wide variety of conditions,including but not limited to sleep apnea, snoring, class IImalocclusion, and/or class III malocclusion.

In one aspect, an apparatus for treating a patient via mandibularadvancement or retraction comprises a plurality of anchoring devices forpositioning in the patient's intraoral cavity. Each of the plurality ofanchoring devices can be positioned in the bone of the patient's upperjaw or the bone of the patient's lower jaw. One or more connectingstructures are provided to be removably coupled to and extend betweenthe plurality of anchoring devices in order to displace the lower jawanteriorly or posteriorly relative to the upper jaw when in position inthe patient's intraoral cavity.

Other objects and features of the present invention will become apparentby a review of the specification, claims, and appended figures.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A illustrates a patient's upper and lower jaws in a habitualocclusal position, in accordance with embodiments.

FIG. 1B illustrates a patient's upper and lower jaws in a“mandible-advanced” occlusal position, in accordance with use ofembodiments.

FIG. 2 illustrates a first exemplary oral apparatus which comprises anelastic tension element attachable at an upper end to an anchor on theupper jaw and oriented to elastically draw the lower jaw forward when inposition in a patient's intraoral cavity, in accordance withembodiments.

FIGS. 3A and 3B illustrates a pair of fixed plate embodiments attachableto the upper and lower jaws, optionally through bone anchors located attwo or more attachment points, in accordance with embodiments.

FIG. 4A illustrates an oral apparatus having a rigid or compliantconnecting structure that can support bending and/or shear loads, inaccordance with embodiments.

FIG. 4B illustrates reaction force vectors from the maxilla and mandibleacting on the structure of FIG. 4A, in accordance with embodiments.

FIG. 5A illustrates an oral apparatus having a connecting structurecouplable to the jaws via a pin anchoring device and pivot anchoringdevice, in accordance with embodiments.

FIG. 5B illustrates an oral apparatus having a connecting structurecouplable to the jaws via two pivot anchoring devices, in accordancewith embodiments.

FIG. 6 illustrates reaction force vectors from the maxilla and mandibleacting on a connecting structure that can support moment loads when inposition in a patient's intraoral cavity, in accordance withembodiments.

FIG. 7 illustrates a combination elastic/fixed plate oral apparatus, inaccordance with embodiments.

FIG. 8 illustrates a bone anchor with a mating feature for locating arigid element which is part of an oral apparatus, in accordance withembodiments.

FIG. 9A illustrates a tooth repositioning appliance, in accordance withembodiments.

FIG. 9B illustrates a tooth repositioning system, in accordance withembodiments.

FIG. 10 illustrates a method of orthodontic treatment using a pluralityof appliances, in accordance with use of embodiments.

FIG. 11 illustrates an apparatus for mandibular advancement orretraction useable in combination with tooth repositioning aligners, inaccordance with embodiments.

FIGS. 12A and 12B illustrate alternate positions for the treatment ofapnea during sleep and the treatment of class I or class III occlusionsduring waking hours, in accordance with use of embodiments.

FIG. 13A illustrates an apparatus providing a limited range of verticaljaw movements when in position in a patient's intraoral cavity, inaccordance with embodiments.

FIGS. 13B and 13C illustrate sectional views of connecting structuresfor controlling vertical jaw movements when in position in a patient'sintraoral cavity, in accordance with embodiments.

DETAILED DESCRIPTION

A better understanding of the features and advantages of the presentdisclosure will be obtained by reference to the following detaileddescription that sets forth illustrative embodiments, in which theprinciples of embodiments of the present disclosure are utilized, andthe accompanying drawings.

As used herein the terms “torque” and “moment” are treated synonymously.

As used herein the term “and/or” is used as a functional word toindicate that two words or expressions are to be taken together orindividually. For example, A and/or B encompasses A alone, B alone, andA and B together.

Systems, methods, devices and apparatus for mandibular advancementand/or retraction via bone attachment are described herein. In variousaspects, an apparatus for treating a patient via mandibular advancementor retraction comprises a plurality of anchoring devices for positioningin the patient's intraoral cavity. Each of the plurality of anchoringdevices can be positioned in bone of the patient's upper jaw or bone ofthe patient's lower jaw. One or more connecting structures can beremovably coupled to and extend between the plurality of anchoringdevices in order to displace the lower jaw anteriorly or posteriorlyrelative to the upper jaw.

In various aspects, a method for treating a patient via mandibularadvancement or retraction comprises positioning a plurality of anchoringdevices in the patient's intraoral cavity. Each of the plurality ofanchoring devices can be positioned in bone of the patient's upper jawor bone of the patient's lower jaw. The method can comprise removablycoupling one or more connecting structures to the plurality of anchoringdevices. The one or more connecting structures can extend between theplurality of anchoring devices in order to displace the lower jawanteriorly or posteriorly relative to the upper jaw.

In some embodiments, the one or more connecting structures are arrangedto displace the lower jaw anteriorly relative to the upper jaw when inposition in a patient's intraoral cavity in order to treat sleep apneain the patient. Alternatively or in combination, other types of jawdisplacements can be produced to treat other conditions, e.g., class IIor class III malocclusions. If desired, the embodiments herein can alsobe used to control jaw displacement along other directions, e.g., alonga lateral (left-right) direction, a vertical (jaw opening-closing)direction, or combinations thereof.

The one or more connecting structures can extend between the pluralityof anchoring devices in order to displace the lower jaw to a targetlocation along an anterior-posterior direction during use. In someembodiments, the one or more connecting structures are arranged toproduce an anterior-posterior force component that displaces the lowerjaw anteriorly or posteriorly relative to the upper jaw during use. Theanterior-posterior force component can be produced by the one or moreconnecting structures independently of a vertical force componentproduced by the one or more connecting structures. For example, the oneor more connecting structures, when coupled to the plurality ofanchoring devices, may be capable of producing an anterior-posteriorforce component without producing a vertical force component.Optionally, the one or more connecting structures, when coupled to theplurality of anchoring devices, may produce the anterior-posterior forcecomponent with a magnitude greater than a magnitude of a vertical forcecomponent, or may produce the anterior-posterior force component withoutproducing a vertical force component.

In some embodiments, the one or more connecting structures and theplurality of anchoring devices are arranged to constrain verticaldisplacement of the lower jaw relative to the upper jaw when in positionin a patient's intraoral cavity. For instance, the vertical displacementcan be constrained in order to inhibit bruxing and/or inhibit contactbetween teeth of the lower jaw and teeth of the upper jaw.

Various types of connecting structures can be used in order to producemandibular advancement and/or retraction without producing unwantedvertical jaw movements, e.g., in order to inhibit bruxing. For example,the one or more connecting structures comprise at least one connectingstructure configured to support one or more of a bending load or a shearload to allow application of anterior-posterior force componentsindependently of vertical force components. For example, the one or moreconnecting structures can comprise at least one stiff structure, atleast one elastic structure, or combinations thereof. In someembodiments, the one or more connecting structures comprise at least oneelastic structure, and the elastic structure can comprise a spring or anelastic band. Optionally, the at least one elastic structure cancomprise a stiffness sufficient to support one or more of a bending loador a shear load.

In some embodiments, the one or more connecting structures comprise atleast one stiff structure and the design of the stiff structure can bevaried as desired. In some embodiments, the at least one stiff structurecomprises a stiffness of at least about 5 N/mm. The at least one stiffstructure can comprise a stiffness sufficient to support one or more ofa bending load or a shear load. The at least one stiff structure cancomprise a stiff plate. The stiff plate can be removably coupled tothree or more of the plurality of anchoring devices. The stiff plate canbe removably coupled to two or more anchoring devices positioned in thebone of the upper jaw. The stiff plate can be removably coupled to twoor more anchoring devices positionable in the bone of the lower jaw.

The one or more connecting structures can be arranged to apply a momentto at least one of the upper jaw or the lower jaw when in position in apatient's intraoral cavity. The moment can result from advancing and/orretracting the mandible without producing unwanted vertical jawmovements. The one or more connecting structures can be arranged toapply the moment to the upper jaw and/or lower jaw when in position in apatient's intraoral cavity. The moment can be applied by a connectingstructure configured to support a bending and/or shear load in order toapply the moment. The connecting structure can be coupled to the upperjaw or the lower jaw via at least one anchoring device that constrainsrotation of the connecting structure along at least one direction ofrotation in order to apply the moment at a location near the at leastone anchoring device.

In some embodiments, the one or more connecting structures areconfigured to perform one or more of the following functions when inposition in a patient's intraoral cavity: produce an anterior-posteriorforce component independently of a vertical force component, produce ananterior-posterior force component without producing a vertical forcecomponent, support a bending load and/or a shear load, or apply a momentto the upper jaw and/or lower jaw.

Any number and combination of anchoring devices can be used inaccordance with embodiments herein. For instance, the plurality ofanchoring devices can comprise three or more anchoring devices. Theanchoring devices can be coupled to the connecting structures usingvarious mechanisms. In some embodiments, the one or more connectingstructures are removably couplable to the plurality of anchoring devicesby, for example, snap-fit couplings, magnetic couplings, interferencefits, locking surfaces, adhesives, removable fasteners, cam locks,interlocking mechanical couplings, fastening features, or combinationsthereof. The one or more connecting structures can be removably coupledto the plurality of anchoring devices such that the one or moreconnecting structures can be coupled to and removed from the pluralityof anchoring devices by the patient. In some embodiments, the one ormore connecting structures are removably couplable to the plurality ofanchoring devices such that the one or more connecting structures can becoupled to and removed from the plurality of anchoring devices by thepatient without using tools. Alternatively, the one or more connectingstructures can be removably coupled to the plurality of anchoringdevices such that the one or more connecting structures can be coupledto and removed from the plurality of anchoring devices by the patientusing a tool (e.g., a simple tool customized for use with the connectingstructures).

In some embodiments, a connecting structure can be coupled to ananchoring device and another appliance or device located in thepatient's intraoral cavity. For example, the one or more connectingstructures can include at least one connecting structure removablycoupled to at least one anchoring device and a shell appliance which canbe positioned on the upper jaw or the lower jaw. The one or moreconnecting structures can include at least one connecting structureremovably coupled to at least one anchoring device and an attachmentpositionable on at least one tooth of the upper jaw or the lower jaw.The plurality of anchoring devices can include at least one dentalimplant (e.g., a dental prosthesis implanted in bone of the jaw such asa crown or bridge) positionable in the upper jaw or the lower jaw of thepatient and the one or more connecting structures comprise at least oneconnecting structure removably couplable to the at least one dentalimplant.

In some embodiments, the one or more connecting structures comprise atleast one connecting structure having a shape customized to thepatient's oral geometry.

In various aspects, an apparatus for treating a patient via mandibularadvancement and retraction comprises a plurality of anchoring devicespositionable in the patient's intraoral cavity. Each of the plurality ofanchoring devices can be positioned in bone of the patient's upper jawor bone of the patient's lower jaw. A first one or more connectingstructures can be removably couplable to and extendable between a firstsubset of the plurality of anchoring devices during a first treatmentphase in order to displace the lower jaw anteriorly relative to theupper jaw during the first treatment phase. A second one or moreconnecting structures can be removably couplable to and extendablebetween a second subset of the plurality of anchoring devices during asecond treatment phase so as to displace the lower jaw posteriorlyrelative to the upper jaw during the second treatment phase. Optionally,the first and/or second one or more connecting structures can be used incombination with an orthodontic appliance (e.g., a tooth repositioningaligner).

In various aspects, a method for treating a patient via mandibularadvancement and retraction comprises positioning a plurality ofanchoring devices in the patient's intraoral cavity. Each of theplurality of anchoring devices can be positioned in bone of thepatient's upper jaw or bone of the patient's lower jaw. The method cancomprise removably coupling a first one or more connecting structures toa first subset of the plurality of anchoring devices, wherein the firstone or more connecting structures extend between the first subset of theplurality of anchoring devices in order to displace the lower jawanteriorly relative to the upper jaw during a first treatment phase. Themethod can comprise removably coupling a second one or more connectingstructures to a second subset of the plurality of anchoring devices,wherein the second one or more connecting structures extend between thesecond subset of the plurality of anchoring devices in order to displacethe lower jaw posteriorly relative to the upper jaw during a secondtreatment phase.

The embodiments provided herein can be used in various types oforthodontic treatments. For example, the first treatment phase caninclude treatment for sleep apnea of the patient and the secondtreatment phase comprises treatment for a malocclusion of the patient.The malocclusion can include a class III malocclusion. The firsttreatment phase can be performed when the patient is asleep and thesecond treatment phase can be performed when the patient is awake.

In some embodiments, the first one or more connecting structures differfrom the second one or more connecting structures. The first subset ofthe plurality of anchoring devices can differ from the second subset ofthe plurality of anchoring devices.

In some embodiments, the first one or more connecting structures arearranged to produce an anterior force component that displaces the lowerjaw anteriorly relative to the upper jaw, and the second one or moreconnecting structures are arranged to produce a posterior forcecomponent that displaces the lower jaw posteriorly relative to the upperjaw. The anterior force component can be produced by the first one ormore connecting structures independently of a vertical force componentproduced by the first one or more connecting structures, and theposterior force component can be produced by the second one or moreconnecting structures independently of a vertical force componentproduced by the second one or more connecting structures. At least oneof the first one or more connecting structures or the second one or moreconnecting structures can be configured to constrain verticaldisplacement of the lower jaw relative to the upper jaw. In someembodiments, at least one of the first one or more connecting structuresor the second one or more connecting structures is configured to supportone or more a bending load or a shear load. For instance, at least oneof the first one or more connecting structures or the second one or moreconnecting structures can comprise at least one stiff structure. In someembodiments, at least one of the first one or more connecting structuresor the second one or more connecting structures is arranged to apply amoment to at least one of the upper jaw or the lower jaw

In various aspects, methods are provided herein for providing any of theapparatus described herein.

In some aspects, systems, methods, devices and apparatus describedherein include methods for treating sleep apnea in a patient, saidmethods including placing an oral appliance in the patient's mouth,wherein the appliance removably attaches at one location to one or morebone anchors in the patient's upper jaw and wherein the applianceremovably attaches at another location to the patient's lower jaw,wherein the appliance imparts a force between the upper jaw and thelower jaw which advances the lower jaw to inhibit apnea in the patient.The appliance can be used to position the mandible and support anyforces and/or moments needed to produce the desired positioning. In someaspects, the patient inserts and removes the appliance from thepatient's mouth. The appliance can include elastic elements, stiffelements, and/or combinations thereof. In some aspects, the applianceremovably attaches to two or more bone anchors in the patient's upperjaw and/or in the patient's lower jaw. The bone anchors and theattachment location on the appliance can be configured to self-centerwhen the appliance is secured to the anchors.

Although some embodiments herein are described in the context ofmandibular advancement, it shall be appreciated that the systems,methods, devices, and apparatus of the present disclosure are equallyapplicable to producing and/or controlling other types of jaw movements,such as mandibular retraction, lateral jaw movements, vertical jawmovements, etc. Additionally, although some embodiments herein arepresented in the context of sleep apnea treatment, this is not intendedto be limiting, and it shall be understood that the systems, methods,devices, and apparatus of the present disclosure can be applied to treatany condition where mandibular advancement and/or retraction isbeneficial, such as class II or class III malocclusions, TMJdysfunction, and so on.

Turning now to the drawings, in which like numbers designate likeelements in the various figures, FIG. 1A illustrates an upper jaw 100and a lower jaw 102 of a patient in a habitual occlusal position, inaccordance with embodiments. The habitual occlusal position cancorrespond to the normally closed position of the upper and lower jaws100, 102. Patients suffering from sleep apnea may experience restrictedairflow due to blockage of the upper airway if the upper and lower jaws100, 102 remain in their habitual occlusal relationship during sleep dueto relaxation of soft tissue in or around the upper airway.

FIG. 1B illustrates the upper jaw 100 and lower jaw 102 in a“mandible-advanced” occlusal position, in accordance with use ofembodiments. In the advanced position, the lower jaw 102 has beendisplaced from its habitual position along an anterior direction(indicated by arrow 104) such that the lower jaw 102 is now positionedanteriorly relative to the upper jaw 100. The advanced position of thelower jaw 102 can be used to tighten the soft tissues of the upperairway, thus maintaining unobstructed airflow during sleep.

In some embodiments, apparatus and methods are provided for mandibularadvancement where forces which protrude the mandible (lower jaw) arearranged to be applied directly to the upper and/or lower jaw bones,rather than indirectly via the teeth. Usually no or reduced forces willbe applied to the teeth in order to reduce or eliminate unintended toothrepositioning or displacement, such as inclination of anterior teeth.Prior to sleep, the patient can removably install an oral apparatus toeffect mandibular advancement, also referred to herein as a mandibularadvancement appliance or device. In some embodiments, the oral apparatusis anchored to both the upper jaw bone (the maxilla) and to the lowerjaw bone (the mandible) and is configured to provide a fixed oradjustable displacement of the lower jaw bone relative to the upper jawbone. For example, the apparatus can apply an anterior force to thelower jaw bone in order to displace the lower jaw anteriorly relative tothe upper jaw.

The displacement position may be fixed, e.g., being provided by arelatively stiff or rigid connecting structure such as a plate or otherfixture which maintains a fixed displacement between the upper and lowerjaws. In other embodiments, the displacement position may be variable,e.g., resulting from a relatively compliant or flexible connectingstructure such as spring or other elastic attachment been the upper andlower jaws. In still other embodiments, the displacement may becontinuously or variably adjustable. Such adjustable apparatus mayemploy motors or other adjustment mechanisms as described in co-pendingU.S. application Ser. No. 14/992,175, filed Jan. 11, 2016, titled“SYSTEMS AND METHODS FOR POSITIONING A PATIENT′S MANDIBLE IN RESPONSE TOSLEEP APNEA STATUS,” the full disclosure of which is incorporated hereinby reference.

In some embodiments, the apparatus provided herein are couplable topermanent or temporary anchoring devices positionable in or on one ormore anatomical structures of the patient's intraoral cavity, such asthe patient's upper and/or lower jaw bones. As used herein “anchor” and“anchoring device” are used interchangeably. By coupling the apparatusto anchoring devices placed in bone, mandibular advancement and/orretraction forces can be applied directly to the patient's jaws and notto the teeth, thus reducing the incidence of unwanted toothrepositioning (e.g., caused by long-term application of advancementand/or retraction forces on the teeth). Anchoring devices can includehardware suitable for fixation into bone, such as bone fasteners,screws, plates, rods, and connectors. The anchoring devices can be madeof metal, glass, composite, plastic, or any other suitable material,and/or combinations thereof. In some embodiments, an anchoring devicecan include a screw for securing the anchoring device to a patient'supper and/or lower jaw bones. Optionally, the anchoring device can be adental implant for use in the patient's intraoral cavity, e.g., a screwfor supporting a crown, bridge, or other prosthesis. In someembodiments, one or more holes suitable for securing an anchoring devicesuch as a screw can be drilled into the upper and/or lower jaws and usedto secure one or more anchoring devices.

In performing the methods of the present invention, bone anchoringdevices which may be similar to conventional orthodontic TADs (temporaryanchoring devices) can placed at preselected locations in the bones ofthe patient's upper and lower jaws. The anchors may be temporary butwill often be permanent. Temporary anchors may be similar to TADs of atype commonly used in orthodontic procedures. In some embodiments, sinceexisting TADs are intended to be temporary and sleep apnea generallyrequires long-term treatment, the anchoring devices are likely to needsomewhat different features to allow for long-term use, e.g., as forimplants or hip or knee replacement components. If the anchoring devicesare intended to be for long-term use and/or are permanent, they may beconfigured to encourage bone ingrowth, for example, with appropriateporosity or surface treatments. Permanent anchors can be similar to thepost anchors which are used for tooth replacement, for example.

An apparatus for mandibular advancement can include any suitable numberof anchoring devices, such as one, two, three, four, five, six, seven,eight, nine, ten, or more anchoring devices. The anchoring devices canbe positioned in the patient's upper jaw bone only, lower jaw bone only,or in both the upper and lower jaw bones. The number of anchoringdevices positioned in a patient's intraoral cavity can be optimizedaccording to a desired treatment plan. In some embodiments, one, two,three, four, five, six, seven, eight, nine, ten, or more anchoringdevices are present in the intraoral cavity. Optionally, anchoringdevices can be distributed evenly between the left and right sides ofthe intraoral cavity, such that an even number of anchoring devices isused. The placement of anchoring devices in the left and right sides ofthe intraoral cavity may or may not be symmetric In some embodiments,one, two, three, four, five, or more anchoring devices are positioned inthe bone of the upper jaw. In some embodiments, one, two, three, four,five, or more anchoring devices are positioned in the bone of the lowerjaw. For example, in some embodiments, two anchoring devices arepositioned in the bone of the upper jaw, and two anchoring devices arepositioned in bone of the lower jaw. In some embodiments, one anchoringdevice is positioned in the bone of the upper jaw, and one anchoringdevice is positioned in bone of the lower jaw. In some embodiments, oneanchoring device is positioned in the bone of the upper jaw, and twoanchoring devices are positioned in bone of the lower jaw. In someembodiments, two anchoring devices are positioned in the bone of theupper jaw, and one anchoring device are positioned in bone of the lowerjaw. In some embodiments, more than two anchoring devices are positionedin either or both of the lower jaw and the upper jaw. In someembodiments, one or more anchoring devices positioned in the upper jaware anterior to one or more anchoring devices positioned in the lowerjaw. In some embodiments, one or more anchoring devices positioned inthe upper jaw are posterior to one or more anchoring devices positionedin the lower jaw.

The couplings between the apparatus and the one or more anchoringdevices in the patient's upper and/or lower jaw bones can be removableor non-removable couplings. As used herein, unless otherwise noted,“coupled” can mean either directly coupled or indirectly coupled (e.g.,via one or more intermediate structures such as adapters). As usedherein, unless otherwise noted, “coupled” can mean either removablycoupled or non-removably coupled. As used herein, unless otherwisenoted, “removably coupled” and “releasably coupled” are interchangeableand mean that the coupled structures or elements can be coupled anddecoupled readily by an end-user (e.g., a patient). In some embodiments,a removably coupled structure can be coupled and decoupled by the userwithout aid of a treating professional and/or tools. In otherembodiments, a removably coupled structure can be coupled and decoupledby the user with aid of a simple tool (e.g., a hex key), which may ormay not be customized for use with the removable coupling. Examples ofremovable couplings include but are not limited to snap-fit couplings,magnetic couplings, interference fits, locking surfaces, adhesives,removable fasteners (e.g., hook and loop fasteners such as VELCRO-typefasteners, touch fasteners, thumb screws, nuts, bolts, pins, rivets),cam locks, interlocking mechanical couplings (e.g., mechanical couplingelements that can be decoupled only when in a certain configuration),fastening features (e.g., hooks, loops, bands, posts), and the like. Incontrast, a non-removably coupled structure may be permanently affixedand incapable of separation without being damaged, or may not be capableof being coupled or decoupled by the user without aid of a professionaland/or tools.

In some embodiments, the apparatus includes one or more connectingstructures that can be removably or non-removably coupled to the one ormore anchoring devices and extend between the one or more connectingstructures in order to displace the lower jaw relative to the upper jawto produce mandibular advancement and/or retraction when in position ina patient's intraoral cavity. Any suitable number and combination ofconnecting structures can be used. For example, an apparatus can includeone, two, three, four, five, or more connecting structures to bepositioned in the patient's intraoral cavity. Examples of connectingstructures include but are not limited to bands, rods, plates, springs,strips, 3D printed structures, structures with curved, organic, and/orcustom-fitted shapes, or combinations thereof. The connecting structurescan include structures made of metal, glass, composite, plastic, naturalor synthetic rubber, or any other suitable material, and/or combinationsthereof. Connecting structures can be coupled to anchoring devices usingany suitable coupling mechanism known in the art. For example, asdiscussed above and herein, connecting structures can be coupled toanchoring devices by snap-fit couplings, magnetic couplings,interference fits, locking surfaces, adhesives, removable fasteners, camlocks, interlocking mechanical couplings, fastening features, and thelike.

The connecting structures can be coupled to any suitable number ofanchoring devices in order to produce mandibular advancement and/orretraction forces when in position in a patient's intraoral cavity. Thenumber of anchoring devices positioned in a patient's intraoral cavityand the number of anchoring devices to which one or more connectingstructures are coupled can both vary according to the plan of treatmentand can both be optimized, e.g., so as to eliminate or minimize anobstruction of the airway and/or prevent sleep apnea and/or snoring. Thenumber of anchoring devices positioned in a patient's intraoral cavity,and the number of anchoring devices to which one or more connectingstructures are coupled, can be optimized so as to apply forces to theupper and/or lower jaws that cause a desired or planned displacement ofthe lower jaw relative to the upper jaw. In some embodiments, aconnecting structure is removably coupled to one, two, three, four,five, six, seven, eight, nine, ten or more anchoring devices. Aconnecting structure can be coupled to anchoring devices in the upperjaw only, the lower jaw only, or both jaws. In some embodiments, aconnecting structure is removably coupled to one, two, three, four, fiveor more anchoring devices positioned in the bone of the upper jaw. Insome embodiments, a connecting structure is removably coupled to one,two, three, four, five or more anchoring devices positioned in the boneof the lower jaw.

FIG. 2 illustrates an oral apparatus 200 having an elastic connectingstructure 202, in accordance with embodiments. In FIG. 2, the oralapparatus 200 comprises an elastic connecting structure 202 (depictedherein as an elastic band) to apply forces to the upper and lower jaws204, 206 to open the airway by pulling the lower jaw 206 forwardrelative to the upper jaw 204. When in position in a patient's intraoralcavity, the elastic structure 202 can be removably coupled to the upperand lower jaws 204, 206 via an upper anchoring device 208 in the upperjaw 204 and a lower anchoring device 210 in the lower jaw 206. The upperanchoring device 208 can be positioned anteriorly relative to the loweranchoring device 210 such that the tension in the elastic structure 202applies a tensile force including an anterior force component 212 toadvance the lower jaw 206. Similarly, an equal and opposite posteriorforce component 214 can be applied to the upper jaw 204 by the tensileforce in the elastic structure 202. Because the forces are primarilyapplied directly to the bones rather than to the teeth, unintentionaltooth movement that can be caused by existing dental apparatus used tocorrect sleep apnea is avoided.

In some embodiments, the tension in the elastic structure 202 alsoapplies vertical force components 216, 218 to the patient's jaws 204,206 when in position in a patient's intraoral cavity. “Vertical” or“occlusal” may be used herein to refer to the direction of jaw movementduring jaw opening and/or closing. In some aspects, an occlusal orvertical force and/or displacement of the lower jaw relative to theupper jaw may be undesirable. The application of such vertical forcescan cause undesirable vertical displacement of the patient's jaws, e.g.,jaw opening or jaw closing movements, that may lead to undesirable sideeffects such as muscle strain, teeth grinding or clenching, and TMJpain. As used herein, “vertical displacement” may refer to displacementof the jaws away from a habitual vertical position, e.g., a naturalresting position of the jaws during sleep. The habitual verticalposition may be a mouth open position, mouth closed position, or anyintermediate position, depending on the particular patient. For example,in the embodiment of FIG. 2, the vertical force components 216, 218produced by the tension in the elastic connecting structure 202 maycause the jaws 204, 206 to be pulled together, which may result inundesirable occlusal contact forces and/or bruxing.

In order to avoid such unintentional side effects, various embodimentsherein provide connecting structures coupled to anchoring devices so asto apply a force system and/or one or more moments when in position in apatient's intraoral cavity to produce a desired anterior and/orposterior displacement of the lower jaw relative to the upper jaw whileminimizing, eliminating, or otherwise constraining unwanteddisplacements of the lower jaw relative to the upper jaw. The unwanteddisplacements can be, e.g., unwanted vertical displacements that producejaw opening or jaw closing movements as described herein. For example,the connecting structure(s) can be configured to allow and/or restrictmovement of the lower jaw relative to the upper jaw in any of threetranslational and in any of three rotational dimensions. In someembodiments, the connecting structure creates anterior-posterior(horizontal) movements and/or rotational movements while constrainingvertical movements. In some embodiments, the connecting structure(s) canbe arranged extending between the plurality of anchoring devices inorder to displace the lower jaw to a target location along ananterior-posterior direction.

In some embodiments of the methods, devices, systems and apparatusdescribed herein, an anterior and/or posterior displacement of the lowerjaw relative to the upper jaw produced by the force system and/or one ormore moments during use is greater than a vertical displacement of thelower jaw relative to the upper jaw produced by the force system. Insome embodiments, the force system and/or one or more moments producesubstantially no vertical displacement of the lower jaw relative to theupper jaw during use. In some embodiments, an anterior and/or posteriordisplacement of the lower jaw relative to the upper jaw produced by theforce system and/or one or more moments is greater than a verticaldisplacement of the lower jaw relative to the upper jaw produced by theforce system and the moment. In some embodiments, the force systemand/or one or more moments produce substantially no verticaldisplacement of the lower jaw relative to the upper jaw.

Connecting structures and anchoring devices described herein can bearranged to displace the lower jaw anteriorly with an amount ofanterior-posterior force in an anterior-posterior direction greater thanamounts of force in vertical directions. The connecting structures andanchoring devices can be arranged to inhibit force to the lower jaw invertical directions. The connecting structures and anchoring devices canbe arranged to limit movement of the lower jaw in vertical directionswhen the lower jaw has advanced anteriorly or posteriorly. Theconnecting structures and anchoring devices can be arranged to displacethe lower jaw anteriorly or posteriorly with substantially no verticaldisplacement of the lower jaw relative to the upper jaw. The connectingstructures and anchoring devices can be arranged to displace the lowerjaw anteriorly or posteriorly with an amount of anterior or posteriordisplacement greater than an amount of vertical displacement of thelower jaw relative to the upper jaw. The connecting structures andanchoring devices can be arranged to urge the lower jaw anteriorly orposteriorly with an amount of anterior or posterior displacement greaterthan a vertical amount of displacement of the lower jaw relative to theupper jaw, the vertical displacement comprising no more than about 5%,10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90% or 100%of the anterior or posterior displacement. Optionally, the connectingstructures and anchoring devices can be arranged to permit verticalmovements of the jaws within a certain range while simultaneouslyadvancing or retracting the mandible, as described further herein.

Unwanted displacements such as vertical displacements can be constrainedor eliminated by a variety of ways while still permittinganterior-posterior jaw displacement during use. In some embodiments, theconnecting structures are arranged to produce one or moreanterior-posterior force components independently of vertical forcecomponents in order to inhibit undesirable vertical displacement duringmandibular advancement and/or retraction. Certain types of connectingstructures may not be capable of producing anterior-posterior forcecomponents independently of and/or without producing any vertical forcecomponents, which may result in unwanted vertical jaw movements whenanterior-posterior forces are applied. For instance, structures that arenot capable of supporting bending and/or shear loads (e.g., due toinsufficient stiffness within the sagittal plane) such as elastic bandsmay not be capable of producing an anterior-posterior force componentwithout also applying vertical force components to the jaws. Stiffnesswithin the sagittal plane may refer to stiffness with respect to allthree degrees of freedom of movement within the sagittal plane (e.g.,two degrees of translation and one degree of rotation). Referring againto FIG. 2, in some embodiments, the elastic connecting structure 202 isnot capable of supporting bending and/or shear loads and relies solelyon tensile force to pull the lower jaw 206 forward, such thatanterior-posterior force components 212, 214 cannot be produced withoutalso generating vertical force components 216, 218. A similar result maybe produced by a connecting structure that is not capable of supportingbending and/or shear loads and relies solely on compressive force topush the lower jaw forward.

Accordingly, the characteristics of the connecting structures and/oranchoring devices herein can be selected to permit production andapplication of anterior-posterior force components independently ofvertical force components in use. Such connecting structures, whencoupled to anchoring devices, may be capable of producing ananterior-posterior force component without producing a vertical forcecomponent. In some embodiments, the one or more connecting structures,when coupled to the plurality of anchoring devices, produce ananterior-posterior force component having a magnitude greater than amagnitude of a vertical force component, or produce ananterior-posterior force component without producing any vertical forcecomponent.

Various types of connecting structures can be used to enable productionof anterior-posterior force components independently of any verticalforce components. For example, in some embodiments, the connectingstructure can be a structure capable of supporting bending and/or shearloads, e.g., acts like a beam within the sagittal plane by havingsufficient stiffness to resist bending and/or shear. The bending and/orshear load can be produced, for example, by reaction forces applied bythe jaws on the connecting structure in response to the mandibularadvancement produced by the connecting structure. In some embodiments,such connecting structures can be stiff structures that resistdeformation when a bending and/or shear load is applied. In otherembodiments, a connecting structure that supports a bending and/or shearload can have some amount of compliance and can exhibit some amount ofdeformation when a bending and/or shear load is applied. The extent towhich the connecting structure deforms under a bending and/or shear loadcan be adjusted to achieve a desired degree of control over theresultant jaw configuration. Alternatively or in combination, multipleconnecting structures transmitting loads to multiple anchoring devicescan be used in order to form an assembly capable of supporting bendingand/or shear loads. For example, the connecting structures can bearranged in a truss-like assembly (e.g., the opposing ends of eachconnecting structure are coupled to different anchoring devices suchthat each connecting structure acts as a two-force member) capable ofsupporting bending and/or shear loads.

The properties of the connecting structures described herein can bevaried as desired, e.g., with respect to size (e.g., length, width,thickness), shape, material properties (e.g., stiffness, elasticity),and so on. For instance, in some embodiments, a connecting structure canbe an elastic structure that deforms when placed under a load (e.g.,forces and/or moments). Examples of elastic structures include but arenot limited to bands, plates, strips, springs, spring-loaded devices,and the like. The apparatus herein can include at least one elasticconnecting structure, such as one, two, three, four, five, or moreelastic connecting structures. The stiffness of the elastic structure(e.g., stiffness within the sagittal plane) can be varied as desired. Insome embodiments, the elastic structure has a stiffness less than orequal to about 0.1 N/mm. In some embodiments, the elastic structure hasa stiffness less than or equal to about 1 N/mm. In some embodiments, theelastic structure has a stiffness less than or equal to about 5 N/mm.Through the use of appropriate materials and geometry, the stiffness canbe tailored to achieve desired motion constraints for different loadingsor motions, such as different stiffnesses in the anterior and/orposterior direction versus the vertical direction. Designs can includevariations in which the connecting structure is elastic for someloadings or motions and stiff for others. In some embodiments, theelastic connecting structure is capable of supporting a bending and/orshear load, e.g., has sufficient stiffness within the sagittal plane.

As another example, in some embodiments, the apparatus herein include atleast one stiff connecting structure, such as one, two, three, four,five, or more stiff connecting structures. In some embodiments, a stiffconnecting structure can be a stiff or rigid structure that is resistantto deformation caused by applied loads (e.g., bending and/or shearloads), such as a stiff plate or plate-like structure, rod, or bar. Astiff connecting structure may maintain its shape with minimal or nodistortion when forces and/or moments are applied, e.g., by thepatient's jaws. A stiff connecting structure can be used to supportbending and/or shear loads. In some embodiments, stiff connectingstructures that are stiffer than the elastic structures presented hereincan be used to transmit force from the upper jaw to the lower jaw. Withproper design, these stiff structures can be used in compression ratherthan tension if desired. This can give the doctor more flexibility inplacing the anchoring device, which can allow the doctor to avoidanatomically difficult placements and to have better control indirecting the resulting forces to create the desired jaw position.

A stiff structure can have a stiffness that is greater than that of theelastic structures described herein. In some embodiments, the stiffstructure has a stiffness of at least about 5 N/mm. In some embodiments,the stiff structure has a stiffness of at least about 20 N/mm. In someembodiments, the stiff structure has a stiffness of at least about 100N/m. Accordingly, a stiff connecting structure can be used to maintainthe upper and lower jaws in a fixed position relative to each other andreduce unwanted displacements (e.g., vertical displacements) asdescribed herein. The use of stiff connecting structures can improve thedegree of control over the resultant position of the jaws. Through theuse of appropriate materials and/or geometry, the stiffness can betailored to achieve desired motion constraints for different loadings ormotions, such as different stiffnesses in the anterior and/or posteriordirection versus the vertical direction. Designs can include variationsin which the connecting structure is stiff for some loadings or motionsand elastic for others.

In some embodiments, a connecting structure that produces anteriorand/or posterior displacement of the lower jaw while inhibitingundesirable vertical displacements will apply one or moments to theupper jaw, the lower jaw, or both when in position in a patient'sintraoral cavity. A moment may be produced, for example, when theconnecting structure applies anterior-posterior force components to thejaws without applying vertical force components, thus resulting in aforce couple. In some embodiments, a connecting structure capable ofsupporting bending and/or shear loads is also capable of supporting andapplying a moment. A connecting structure capable of supporting andapplying a moment can be a stiff structure that exhibits substantiallyno deformation under load, such as the embodiments described herein. Inother embodiments, a connecting structure used for applying moments tothe jaw(s) can be an elastic structure that exhibits some degree ofcompliance (e.g., experiences some deformation under loading), but stillhas sufficient stiffness to support the moment load. For example, aconnecting structure for applying a moment load can have a rotationalstiffness of about 5 N-mm/radian, or from about 0.1 N-mm/radian to about100 N-mm/radian. A connecting structure that has some compliance canreduce patient discomfort, e.g., by permitting relatively smalltranslational and/or rotational movements while maintaining the advancedposition of the lower jaw.

The shape of a connecting structure (stiff or elastic) can be varied asdesired. For example, the structure can be a rod, bar, plate, orplate-like structure. The plate or plate-like structure can besubstantially flat or planar. The plate or plate-like structure can havea circular, elliptical, triangular, rectangular, or other polygonalshape, and/or combinations and/or variants thereof, such as shapeshaving both corners and rounded edges. Optionally, the connectingstructure can have a shape customized to conform the patient's oralgeometry. In such embodiments, the connecting structure can have acurved, organic, and/or irregular shape.

The number and position of anchoring devices to which the connectingstructures are removably coupled can be varied as desired. For example,the number of anchoring devices on the upper and lower jaws can beconfigured to anteriorly displace the lower jaw relative to the upperjaw in use. The number of anchoring devices on the upper and lower jawscan also be configured to restrict vertical movement of the lower jawrelative to the upper jaw. To achieve a desired or planned displacementof the lower jaw relative to the upper jaw, the connecting structure canbe removably coupled to one or more anchoring devices positioned asdesired on the upper jaw and one or more anchoring devices positioned asdesired on the lower jaw. In some cases, it may be desirable for theconnecting structure to be couplable to one anchoring device on thelower jaw and more than one anchoring device on the upper jaw. In othercases, it may be desirable for the connecting structure to be couplableto one anchoring device on the upper jaw and more than one anchoringdevice on the lower jaw. In still other cases, it may be desirable forthe connecting structure to be couplable to more than one anchoringdevice on both the upper jaw and the lower jaw.

FIGS. 3A and 3B illustrate apparatus with connecting structures capableof applying anterior-posterior force components independently of anyvertical force components when in position in a patient's intraoralcavity, in accordance with embodiments. By using plates which optionallyare securable to two or more anchors in either or both jaws, both therelative advancement and degree of opening of the jaws can becontrolled. In FIG. 3A, apparatus 300 comprises a triangular plate-likeconnecting structure 306 that is coupled to anchoring device 308positioned on upper (maxillary) jaw 302 and coupled to anchoring devices310 and 312 positioned on lower jaw 304. The connecting structure 306can have sufficient stiffness within the sagittal plane to be capable ofsupporting bending and/or shear loads. Anchoring devices 308, 310 and312 can be positioned such that the connecting structure 306 applies ananterior force 322 on lower jaw 304 that causes anterior displacement ofthe lower jaw relative to the upper jaw. A corresponding posterior force324 can be applied on the upper jaw 302 by the connecting structure 306.Forces 322, 324 form a force couple resulting in a moment being appliedto the jaws. In order to be in equilibrium, the jaws may apply acounteracting moment (not shown) to the connecting structure 306. Theanterior-posterior forces 322, 324 can be applied by the connectingstructure 306 to the jaws independently of any vertical forcecomponents, such that there is no tendency of the jaws to be pulledtogether or pushed apart when the apparatus 300 is worn.

Optionally, in some embodiments, the geometry (e.g., height) of theconnecting structure 306 can be selected to bias the jaws in a desiredvertical configuration when in position in a patient's intraoral cavity,e.g., a partially open configuration that inhibits bruxing. Movement ofthe jaws away from the configuration defined by the connecting structuregeometry may result in generation of vertical forces on the jaws as theconnecting structure 306 restricts the movement of the jaws. Forexample, the upper jaw 302 may apply a downward vertical force 320 toconnecting structure 306 through anchoring device 308 and lower jaw 304may apply an upward vertical force 314 to connecting structure 306through anchoring devices 310 and 312, e.g., when the patient attemptsto close their jaws. In this embodiment, vertical displacement of thelower jaw relative to the upper jaw can be restricted because connectingstructure 306 is sufficiently stiff to resist the loads from the upperand lower jaws and is securely coupled to anchoring devices 308, 310 and312 (e.g., does not translate and/or rotate relative to the anchoringdevices 308, 310, 312). Accordingly, connecting structure 306 can applyan upward vertical force 318 to upper jaw 302 through anchoring device308 that is equal and opposite to downward vertical force 320, and canapply a downward vertical force 316 to lower jaw 304 through anchoringdevices 310 and 312 that is equal and opposite to upward vertical force314, thereby reducing or inhibiting movement of the lower jaw relativeto the upper jaw. Similarly, the connecting structure 306 can alsoresist opening movements of the jaws (e.g., upward vertical forcesapplied by the upper jaw and/or downward vertical forces applied by thelower jaw). Alternatively or in combination, the connecting structure306 can exhibit some degree of compliance such that small verticalmovements are permitted even as the jaws are biased into the specifiedconfiguration, e.g., to improve patient comfort.

In FIG. 3B, apparatus 350 comprises rectangular plate-like connectingstructure 356 that, when in position in a patient's intraoral cavity, iscoupled to anchoring devices 358 and 360 positioned on upper (maxillary)jaw 352 and coupled to anchoring devices 362 and 364 positioned on lowerjaw 354. The connecting structure 356 can have sufficient stiffnesswithin the sagittal plane to be capable of supporting bending and/orshear loads. Anchoring devices 358, 360, 362 and 364 can be positionedso as to apply an anterior force 374 that causes anterior displacementof the lower jaw relative to the upper jaw. A corresponding posteriorforce 376 can be applied on the upper jaw 352 by the connectingstructure 356. Forces 374, 376 form a force couple resulting in a momentbeing applied to the jaws, and the jaws may apply a counteracting moment(not shown) to the connecting structure 356. Similar to the embodimentof FIG. 3A, the anterior-posterior forces 374, 376 can be applied by theconnecting structure 356 to the jaws independently of any vertical forcecomponents, such that there is no tendency of the jaws to be pulledtogether or pushed apart when the apparatus 350 is worn.

Similar to the embodiment of FIG. 3A, the geometry of the connectingstructure 356 can be selected to restrict the jaws to a desired verticalconfiguration. Vertical displacement of the lower jaw relative to theupper jaw can be restricted because connecting structure 356 issufficiently stiff and is sufficiently coupled to anchoring devices 358,360, 362 and 364. In some embodiments, if the patient attempts to movethe jaws away from the configuration specified by the connectingstructure 356, upper jaw 352 may apply a downward vertical force 372 toconnecting structure 356 through anchoring devices 358 and 360, andlower jaw 354 may apply an upward vertical force 366 to connectingstructure 356 through anchoring devices 362 and 364. Connectingstructure 356 can apply an upward vertical force 370 to upper jaw 352through anchoring devices 358 and 360 that is equal and opposite todownward vertical force 372, and can apply a downward vertical force 368to lower jaw 354 through anchoring devices 362 and 364 that is equal andopposite to upward vertical force 366, thereby reducing or inhibitingmovement of the lower jaw relative to the upper jaw. Similarly, jawopening movements can also be reduced or inhibited by the connectingstructure 356. Optionally, the connecting structure 356 can exhibit somedegree of compliance such that small vertical movements are permittedeven as the jaws are biased into the specified configuration, e.g., toimprove patient comfort.

FIGS. 4A and 4B illustrate an apparatus with a connecting structurecapable of applying anterior-posterior force components independently ofany vertical force components when in position in a patient's intraoralcavity, in accordance with embodiments. In the embodiment shown in FIG.4A, the apparatus 400 comprises a triangular-shaped plate-likeconnecting structure 412 that can support bending and/or shear loads.Connecting structure 412 can be removably coupled to anchoring devices408 and 409 that are positioned in bone of the patient's upper jaw 402and can be removably coupled to anchoring device 410 that is positionedin bone of the patient's lower jaw 404. Similar to other embodimentspresented herein, the connecting structure 412 and anchoring devices408, 409, 410 can be arranged to apply a force system to advance and/orretract the lower jaw 404 relative to the upper jaw 402.

FIG. 4B illustrates the reaction forces exerted on the plate member ofFIG. 4A by the upper and lower jaws 402, 404 during advancement. Thereaction forces can be applied on the connecting structure 412 by theupper and lower jaws 402, 404 when the lower jaw 404 is anteriorlydisplaced relative to the upper jaw 402 as a result of the force systemapplied by the apparatus 400. In the embodiment shown in FIG. 4B,horizontal reaction forces 456 are applied in an anterior direction toconnecting structure 412 by the upper jaw 402 through anchoring devices408 and 409, and horizontal reaction force 458 is applied in a posteriordirection to connecting structure 412 by the lower jaw 404 throughanchoring device 410, thus resulting in a clockwise rotational reactionforce being applied to connecting structure 412. Downward verticalreaction force 452 is applied to connecting structure 412 by the upperjaw through anchoring device 408, and upward vertical reaction force 454is applied to connecting structure 412 by the upper jaw throughanchoring device 409, resulting in a counter-clockwise rotationalreaction force being applied to connecting structure 412 near theanchoring devices 408, 409. Connecting structure 412 can have sufficientstiffness to support bending and/or shear loads such as reaction forces452, 454, 456 and 458.

Various types of anchoring devices can be used in combination with theconnecting structures described herein in order to allow the apparatusto apply moments to the jaws and/or support bending and/or shear loads.In some embodiments, the anchoring device can allow and/or constraincertain movements of the connecting structure relative to the anchoringdevice (e.g., with respect to up to three degrees of freedom intranslation and up to three degrees of freedom in rotation) when theconnecting structure is coupled to the anchoring device. Constraint oftranslational and/or rotation movements can allow the connectingstructure to support bending and/or shear loads at or near the coupledanchoring device(s). Optionally, an anchoring device can permit certainmovements while inhibiting other movements. For example, a rotatableanchoring device (e.g., a pivot, ball joint, pin, etc.) can permit someor all rotational movements of a coupled connecting structure relativeto the anchoring device while constraining some or all translationalmovements of the connecting structure. In some embodiments, a freelyrotatable anchoring device (e.g., a pivot, ball joint) permitsrotational movement of the connecting structure about to the anchoringdevice with respect to three degrees of freedom in rotation. A freelyrotatable anchoring device may constrain some or all translationalmovement of the connecting structure relative to the anchoring device.As another example, a partially rotatable anchoring device can constrainsome rotational movements of a coupled connecting structure. In someembodiments, a pin anchoring device permits rotation of the connectingstructure about the axis of the pin only and constrains rotationalmovements in other directions. A partially rotatable anchoring devicemay constrain some or all translational movement of the connectingstructure relative to the anchoring device. For instance, a pinanchoring device may or may not permit translation of connectingstructure along the pin axis. In yet another example, a non-rotatableanchoring device can constrain all rotational movements of a coupledconnecting structure. A non-rotatable anchoring device may constrainsome or all translational movement of the connecting structure relativeto the anchoring device.

In some embodiments, rotational constraint of a connecting structure byan anchoring device (e.g., with respect to one, two, or three degrees ofrotational freedom) can enable the connecting structure to supportand/or transmit moment loads to the jaw at or near the location of theanchoring device. For instance, a connecting structure can apply amoment at or near the location of a partially rotatable or non-rotatableanchoring device. A connecting structure can be coupled to any suitablenumber and combination of anchoring device types (e.g., only pinanchoring devices, only pivot anchoring devices, a combination of pinand pivot anchoring devices, etc.) in order to produce moments on thejaws at one or more specified locations.

For instance, referring again to FIG. 4A, the anchoring devices 408,409, and 410 can be pivot anchoring devices. The pivot anchoring devicescan be two-dimensional pivots that permit rotation of the connectingstructure 412 within the vertical plane, thus allowing the mandible 404to rotate relative to the maxilla 402. Optionally, the pivot anchoringdevices can be three-dimensional pivots that also permit rotation of theconnecting structure 412 within the transverse plane. The use ofthree-dimensional pivots can permit at least some side-to-side motionsof the mandible (e.g., along the transverse direction) even as theapparatus forces the mandible to advance anteriorly, to improve patientcomfort.

In the embodiment shown in FIG. 5A, apparatus 500 comprises connectingstructure 510 which when in position in a patient's intraoral cavity arecoupled to pin anchoring device 506 positioned on maxillary jaw bone 502and pivot anchoring device 508 positioned on mandibular jaw bone 504. Inother embodiments, the pin anchoring device 506 can be positioned on themandible 504 and the pivot anchoring device 508 can be positioned on themaxilla 502. Pin anchoring device 506 can be a partially rotatableanchoring device that permits rotation of connecting structure 510 aboutthe longitudinal pin axis only and restricts all other rotationalmovements of connecting structure 510. Optionally, pin anchoring device506 can also constrain horizontal (anterior-posterior) sliding movementsof connecting structure 510 along the horizontal (anterior-posterior)axis of pin anchoring device 506. In contrast, pivot anchoring device508 can restrict translational sliding movements of connecting structure510 while allowing rotational movements of connecting structure 510about a pivoting axis centered about pivot anchoring device 508.Accordingly, the apparatus 500 can permit some rotation of the mandible504 relative to the maxilla 502, which can increase patient comfort.Additionally, due to the rotational constraint placed on the connectingstructure 510 by the pin anchoring device 506, the connecting structure510 can apply a moment to the maxilla 502 near the pin anchoring device506.

In the embodiment shown in FIG. 5B, apparatus 550 comprises connectingstructure 560 which when in position in a patient's intraoral cavity iscoupled to pin anchoring device 556 positioned on maxillary jaw bone 552and is coupled to pin anchoring device 558 positioned on mandibular jawbone 554. Pin anchoring devices 556 and 558 can restrict rotationalmovements of connecting structure 560 while allowing for substantiallyhorizontal (anterior-posterior) sliding movements of connectingstructure 560 along the horizontal (anterior-posterior) axes of pinanchoring devices 556 and 558. The apparatus 550 can restrict therotation of the mandible 554 relative to the maxilla 552. The rotationalconstraints of the connecting structure 560 at pin anchoring devices556, 558 can allow the connecting structure 560 to apply moments to themaxilla 556 and mandible 554 near pin anchoring devices 556, 558respectively.

FIG. 6 is a free body diagram 600 depicting forces applied to aconnecting structure 608, in accordance with embodiments. Similar to theembodiment of FIG. 5A, connecting structure 608 is coupled to themaxilla when in position in a patient's intraoral cavity via a pinanchoring device 610 and the mandible via a pivot anchoring device 612,respectively. The connecting structure 608 and anchoring devices 610,612 can be arranged such that the connecting structure 608 displaces themandible in the anterior direction in use, resulting in the mandibleapplying a posterior reaction force 606 on the connecting structure 608at anchoring device 612, the maxilla applying an anterior reaction force602 on the connecting structure 608 at anchoring device 610, and themaxilla applying a counterclockwise moment 604 on the connectingstructure 608 at anchoring device 610.

The different types of connecting structures described herein can becombined in various ways to produce a force system for mandibularadvancement while limiting unwanted jaw displacements. In someembodiments, for instance, the connecting structures can include acombination of elastic and stiff structures described herein in order toapply a desired force system, e.g., to permit certain jaw movementswhile restricting others. The connecting structures can include stiffstructures combined with flexing or compliant structures such aselastics or other springs or spring-like features that allow the flexingstructures to be mounted at locations such as particular targetlocations on the patient's jaw. Specific anchoring locations can beselected to align the forces generated as desired, e.g., to pull and/orpush the mandible forward without also creating jaw opening or closingforces. The oral apparatus may alternatively comprise stiff structuresor only slightly compliant structures to lock the relationship of themandible and maxilla in place. Stiff and compliant regions may also bebuilt into the same apparatus attached to the anchoring devices so thata single part (or optionally a left-right pair of parts) can provide theadvantages described above with a simple, low cost device. In order toanchor stiff or compliant parts that need to carry moment loads,multiple anchoring devices may be used and/or the anchor devices may bebuilt so that each can constrain multiple degrees of freedom. Thepresent disclosure includes embodiments optionally using connectingstructures (e.g., plates) which may have both relatively stiff (morerigid) portions and relatively elastic (less rigid) portions in a singlestructure or assembly to create the desired mechanical behavior, forexample by appropriate design of the part geometry, through the use of aplurality of materials, or both.

FIG. 7 shows apparatus 700 having a combination of relatively stiff andrelative elastic connecting structures, in accordance with embodiments.Stiff connecting structure 706 can be an L-shaped plate that isremovably couplable to three anchoring devices 710 positioned on lowerjaw 704 that fully support stiff connecting structure 706. Stiffconnecting structure 706 can also be removably coupled to elasticconnecting structure 708 at coupling portion 712 of the stiff connectingstructure 706. Elastic connecting structure 708 can be removably coupledto anchoring device 714 positioned on upper jaw 702 such that thetension in elastic connecting structure 708 applies anterior force (F)716 to stiff connecting structure 706 at coupling portion 712.Accordingly, stiff connecting structure 708 applies posterior force tolower jaw 704 via point anchors 710. In some embodiments, the elasticconnecting structure 708 and stiff connecting structure 706 are discretecomponents and are arranged and configured to draw or pull the mandibleforward in an anterior direction in use without also creating verticalopening or closing forces of the jaws, or clenching of the teeth. Forexample, if the force 716 exerted by elastic connecting structure 708 issubstantially aligned with the center of rotation of the TMJ, the forceson the upper and lower jaws 702, 704 will not substantially rotate thelower jaw 704 open or closed. In alternative embodiments, the elasticconnecting structure 708 and stiff connecting structure 706 can bearranged to produce jaw opening and/or closing movements if desired.

Anchoring devices of the present disclosure can have features to controlthe position and/or orientation of one or more connecting structures,and/or to provide for adequate coupling to the connecting structures. Insome embodiments, anchoring devices have features configured towithstand applied forces and/or moments without substantially deformingor decoupling from one or more connecting structures. Anchoring devicesdescribed herein can comprise features such as pins, screws (includingbut not limited to thumbscrews), snap-fit couplings, magnetic couplings,nuts, bolts, rivets, interference fits, locking surfaces, adhesives,removable fasteners (e.g., hook and loop fasteners, touch fasteners),cam locks, interlocking mechanical couplings and/or other fastenersand/or engaging elements, and/or variants thereof and/or combinationsthereof, in part or in their entirety. In some embodiments, an anchoringdevice can include a mating feature that engages and mates with acorresponding mating feature on a connecting structure in order toimprove the stability of the coupling between the anchoring device andconnecting structures. A mating feature can include one or more ofprotrusions, grooves, ribs, flanges, recesses, cavities, apertures,texturing, patterning, interlocking elements, and the like. Optionally,the mating features can be shaped to constrain the connecting structureto a specified position and/or orientation relative to the anchoringdevice, e.g., in order to maintain the connecting structure at a desiredconfiguration relative to the patient's jaws. This can be used toconstrain the jaws to a specific position relative to each other, forexample.

FIG. 8 illustrates part of an apparatus 800 comprising anchoring device802 anchored into bone 804 and removably coupled to connecting structure806 (e.g., a stiff connecting structure) by a mating feature thatcomprises locking surface 808 of the anchoring device 802 that removablyengages and mates with locking surface 810 of the connecting structure806. Anchoring device 802 is optionally also secured to connectingstructure 806 by engaging element 812. The locking surface 808 caninclude, for example, one or more protrusions that are received withincomplementary recesses on the locking surface 810. However, it shall beappreciated that other types of complementary structures can be used toensure a mating fit between the anchoring device 802 and connectingstructure 806. In this embodiment, engaging element 812 comprises aremovable fastener 814 that secures connecting structure 806 toanchoring device 802, but is hand-removable by the patient (e.g., can beremoved without requiring tools), such as a thumbscrew. In otherembodiments, the engaging element comprises other coupling means,including but not limited to snap-fit couplings, magnetic couplings,and/or other couplings of the present disclosure, which may or may notbe patient-removable.

As described above and herein, the apparatus and devices of the presentdisclosure can constrain vertical movements of the lower jaw relative tothe upper jaw while producing mandibular advancement and/or retraction.In some embodiments, the connecting structures and anchoring devicesdescribed herein can be arranged to limit the vertical movement range ofthe jaws (e.g., opening and closing jaw movements) while allowing freemotion of the jaw within that range and, optionally, simultaneouslypositioning the mandible in the anterior and/or posterior direction(e.g. positioning it forward to open the airway for treatment of sleepapnea). For example, the range of motion in closing the jaw can belimited to prevent the possibility of bruxing, while the limit foropening the jaw could be set to allow the maximum natural opening or asmaller opening, as desired. This approach can improve patient comfortduring mandibular advancement and/or retraction by permitting some jawopening and closing movements, while reducing the incidence of unwantedside effects such as teeth clenching and bruxing.

FIG. 13A illustrates an apparatus 1300 providing a limited range ofvertical jaw movements when in position in a patient's intraoral cavity,in accordance with embodiments. The apparatus 1300 includes a connectingstructure 1302 coupled to upper jaw 1304 by anchoring devices 1306, 1308and to lower jaw 1310 by anchoring device 1312. The anchoring device1312 is received within a slot 1314 formed in the connecting structure1302. The anchoring device 1312 can slide within the slot 1314 relativeto the connecting structure 1302 so as to allow the lower jaw 1310 to bemoved vertically relative to the upper jaw 1304 within a limited range.The range can be defined by the positioning and/or geometry of the slot1314. For example, FIG. 13B illustrates a cross-sectional view of aconnecting structure 1316 having a relatively short slot 1318 whichprovides little clearance for vertical motion of the anchoring device1320, thus imposing a relatively severe constraint on the verticalmovements of the jaws. In contrast, FIG. 13C illustrates across-sectional view of a connecting structure 1322 having a relativelylong slot 1324 which provides greater freedom of vertical movement forthe anchoring device 1326, and therefore permits an increased range ofvertical motion for the jaws. Optionally, the slot 1314 can be curved soas to conform to the natural jaw opening and closing trajectory of thepatient. Additionally, the positioning and/or geometry of the slot 1314in the connecting structure 1302 can be used to control the amount ofmandibular displacement produced by the apparatus 1300. For example, theposition of the slot 1314 along the anterior-posterior directionrelative to the natural position of the anchoring device 1312 (e.g.,when the lower jaw 1310 is in a habitual or relaxed position) candetermine the amount of mandibular displacement.

The mandibular advancement and/or retraction apparatus described hereincan be used in conjunction with other intraoral appliances. The otherappliance can be positioned on the upper jaw or the lower jaw. The otherappliance can include a shell appliance (e.g., polymeric shellappliance), such as a tooth-repositioning appliance. The shell appliancecan have teeth-receiving cavities shaped to receive and apply aresilient positioning force (e.g., tooth repositioning force) to thepatient's teeth. In alternative embodiments, the teeth-receivingcavities can be shaped to maintain a current tooth arrangement, suchthat the shell appliance serves as a retainer for the teeth. Optionally,a shell appliance can reposition some teeth while maintaining otherteeth in a current arrangement. In some embodiments, other types oftooth repositioning appliances can be used, such as wire-and-bracketappliances (e.g., braces).

As discussed herein, some embodiments of the systems, methods, devicesand apparatus for mandibular advancement and/or retraction of thepresent disclosure produce displacements of the upper and/or lower jawsby applying forces directly to the bone of the jaws, with minimal or noforces applied to teeth or to periodontal ligaments. Accordingly, someembodiments of the systems, methods, devices and apparatus describedherein can be used effectively in combination with tooth repositioningappliances because the mandibular displacement approaches describedherein do not interfere with tooth repositioning forces applied by toothrepositioning appliances such as aligners. Advantageously, this allowsfor orthodontic treatments to be applied to the patient's teeth inconjunction with the mandibular advancement and/or retraction therapy.

In some embodiments, the apparatus presented herein can be combined withorthodontic treatment, particularly orthodontic treatment with removablealigners such as those available under the trade name Invisalign® fromAlign Technology, Inc. as described herein. If the patient has class IIor class III malocclusions, for example, and movement of the teeth inthe jaw is desired, the connecting structures can be attached to buttonsor hooks on the upper or lower aligner to generate the desired forces.By using one or more anchoring devices, teeth on one jaw can be movedwithout moving teeth on the other.

FIG. 9A illustrates an exemplary tooth repositioning appliance oraligner 900 suitable for incorporation with the embodiments describedherein. The appliance 900 can be worn by a patient in order to achievean incremental repositioning of individual teeth 902 in the jaw. Theappliance can include a shell (e.g., a continuous polymeric shell or asegmented shell) having teeth-receiving cavities that receive andresiliently reposition the teeth. In one embodiment, an appliance orportion(s) thereof may be indirectly fabricated using a physical modelof teeth. For example, an appliance (e.g., polymeric appliance) can beformed using a physical model of teeth and a sheet of suitable layers ofpolymeric material. An appliance can fit over all teeth present in anupper or lower jaw, or less than all of the teeth. The appliance can bedesigned specifically to accommodate the teeth of the patient (e.g., thetopography of the tooth-receiving cavities matches the topography of thepatient's teeth), and may be fabricated based on positive or negativemodels of the patient's teeth generated by impression, scanning, and thelike. Alternatively, the appliance can be a generic appliance configuredto receive the teeth, but not necessarily shaped to match the topographyof the patient's teeth. In some cases, only certain teeth received by anappliance will be repositioned by the appliance while other teeth canprovide a base or anchor region for holding the appliance in place as itapplies force against the tooth or teeth targeted for repositioning. Insome cases, many or most, and even all, of the teeth will berepositioned at some point during treatment. Teeth that are moved canalso serve as a base or anchor for holding the appliance as it is wornby the patient. Typically, no wires or other means will be provided forholding an appliance in place over the teeth. In some cases, however, itmay be desirable or necessary to provide individual attachments or otheranchoring elements 904 on teeth 902 with corresponding receptacles orapertures 906 in the appliance 900 so that the appliance can apply aselected force on the tooth. Exemplary appliances, including thoseutilized in the Invisalign® System, are described in numerous patentsand patent applications assigned to Align Technology, Inc. including,for example, in U.S. Pat. Nos. 6,450,807, and 5,975,893, as well as onthe company's website, which is accessible on the World Wide Web (see,e.g., the url “invisalign.com”). Examples of tooth-mounted attachmentssuitable for use with orthodontic appliances are also described inpatents and patent applications assigned to Align Technology, Inc.,including, for example, U.S. Pat. Nos. 6,309,215 and 6,830,450.

FIG. 9B illustrates a tooth repositioning system 910 including aplurality of appliances 912, 914, 916. Any of the appliances describedherein can be designed and/or provided as part of a set of a pluralityof appliances used in a tooth repositioning system. Each appliance maybe configured so a tooth-receiving cavity has a geometry correspondingto an intermediate or final tooth arrangement intended for theappliance. The patient's teeth can be progressively repositioned from aninitial tooth arrangement to a target tooth arrangement by placing aseries of incremental position adjustment appliances over the patient'steeth. For example, the tooth repositioning system 910 can include afirst appliance 912 corresponding to an initial tooth arrangement, oneor more intermediate appliances 914 corresponding to one or moreintermediate arrangements, and a final appliance 916 corresponding to atarget arrangement. A target tooth arrangement can be a planned finaltooth arrangement selected for the patient's teeth at the end of allplanned orthodontic treatment. Alternatively, a target arrangement canbe one of many intermediate arrangements for the patient's teeth duringthe course of orthodontic treatment, which may include various differenttreatment scenarios, including, but not limited to, instances wheresurgery is recommended, where interproximal reduction (IPR) isappropriate, where a progress check is scheduled, where anchor placementis best, where palatal expansion is desirable, where restorativedentistry is involved (e.g., inlays, onlays, crowns, bridges, implant,veneers, and the like), etc. As such, it is understood that a targettooth arrangement can be any planned resulting arrangement for thepatient's teeth that follows one or more incremental repositioningstages. Likewise, an initial tooth arrangement can be any initialarrangement for the patient's teeth that is followed by one or moreincremental repositioning stages.

FIG. 10 illustrates a method 1000 of orthodontic treatment using aplurality of appliances, in accordance with many embodiments. The method1000 can be practiced using any of the appliances or appliance setsdescribed herein. In step 1010, a first orthodontic appliance is appliedto a patient's teeth in order to reposition the teeth from a first tootharrangement to a second tooth arrangement. In step 1020, a secondorthodontic appliance is applied to the patient's teeth in order toreposition the teeth from the second tooth arrangement to a third tootharrangement. The method 1000 can be repeated as necessary using anysuitable number and combination of sequential appliances in order toincrementally reposition the patient's teeth from an initial arrangementto a target arrangement. The appliances can be generated all at the samestage or in sets or batches (e.g., at the beginning of a stage of thetreatment), or one at a time, and the patient can wear each applianceuntil the pressure of each appliance on the teeth can no longer be feltor until the maximum amount of expressed tooth movement for that givenstage has been achieved. A plurality of different appliances (e.g., aset) can be designed and even fabricated prior to the patient wearingany appliance of the plurality. After wearing an appliance for anappropriate period of time, the patient can replace the currentappliance with the next appliance in the series until no more appliancesremain. The appliances are generally not affixed to the teeth and thepatient may place and replace the appliances at any time during theprocedure (e.g., patient-removable appliances). The final appliance orseveral appliances in the series may have a geometry or geometriesselected to overcorrect the tooth arrangement. For instance, one or moreappliances may have a geometry that would (if fully achieved) moveindividual teeth beyond the tooth arrangement that has been selected asthe “final.” Such over-correction may be desirable in order to offsetpotential relapse after the repositioning method has been terminated(e.g., permit movement of individual teeth back toward theirpre-corrected positions). Over-correction may also be beneficial tospeed the rate of correction (e.g., an appliance with a geometry that ispositioned beyond a desired intermediate or final position may shift theindividual teeth toward the position at a greater rate). In such cases,the use of an appliance can be terminated before the teeth reach thepositions defined by the appliance. Furthermore, over-correction may bedeliberately applied in order to compensate for any inaccuracies orlimitations of the appliance.

In some embodiments, a connecting structure of a mandibular advancementand/or retraction apparatus can be coupled to another appliance in thepatient's intraoral cavity. For example, the connecting structure caninclude a first portion coupled to an anchoring device and a secondportion coupled to the appliance. The appliance can be a shellappliance, such as an aligner or retainer. Optionally, the appliance canbe a wire-and-bracket appliance. The coupling between the connectingstructure and appliance can be removable, e.g., patient-removable, andcan utilize any of the coupling mechanisms described herein. Aconnecting structure coupled to another appliance can be used to exertforces and/or moments on the patient's upper and/or lower jaws todisplace the lower jaw. In some embodiments, a connecting structurecoupled to an appliance can be used to exert tooth repositioning forceson teeth received by the appliance.

Alternatively or in combination, the connecting structures can include aconnecting structure coupled to an anchoring device and coupled to anattachment positioned on at least one tooth of the upper jaw or thelower jaw. For example, the connecting structure can include a firstportion coupled to an anchoring device and a second portion coupled tothe attachment. Various attachments, including materials and designs,can be utilized. Attachments can include various materials, e.g., metal,glass, composite, plastic, etc. For example, attachments can be formedby application and in some cases curing of material (e.g., composite) ona tooth surface. Attachment materials can further include variouspre-formed or pre-fabricated components, such as attachment devices.Materials for attachment positioning, such as templates, attachmentmaterials, etc., can optionally be provided to an orthodonticpractitioner for attachment positioning. Mounting an attachment caninclude bonding the attachment to the surface of the patient's tooth.Bonding and attachment positioning can be accomplished according tovarious techniques, including those commonly employed in orthodonticsfor mounting or bonding an attachment or object to a patient's tooth.The coupling between the connecting structure and attachment can beremovable, e.g., patient-removable, and can utilize any of the couplingmechanisms described herein. A connecting structure coupled to anattachment can be used to exert forces and/or moments on the patient'supper and/or lower jaws to displace the lower jaw. Optionally, aconnecting structure coupled to an attachment can be used to exert toothrepositioning forces on the tooth with the attachment.

FIG. 11 illustrates an apparatus 1100 for mandibular advancement and/orretraction used in combination with tooth repositioning aligners, inaccordance with embodiments. In some embodiments, the apparatus 1100 canbe used with retainers or aligners which have attachment elements, suchas (without limitation) hooks, buttons and/or wires and brackets. InFIG. 11, exemplary apparatus 1100 comprises upper tooth repositioningaligner 1114, lower tooth repositioning aligner 115, and connectingstructure 1106 that is removably coupled to anchoring device 1108positioned on upper jaw 1102. Connecting structure 1106 is alsoremovably coupled to attachment element 1116 (e.g., hook, button,bracket) that is attached to lower tooth repositioning aligner 1115. Inother embodiments, the attachment element 1116 can be attached to atooth rather than to the aligner 1115, and the aligner 1115 can includea hole through which the attachment element 1116 extends. In thisconfiguration, the apparatus generates a force system that displaces thelower jaw 1104 in a posterior direction relative to the upper jaw 1102,e.g., to treat malocclusion as part of a combined treatment, asdiscussed further herein. It shall be appreciated that in alternativeembodiments the connecting structure 1106 can be removably coupled in amanner producing anterior displacement of the lower jaw 1104. Connectingstructure 1106 can be removed from anchoring device 1108 and/orattachment element 1116, e.g., by the patient. In alternativeembodiments, other configurations of the connecting structure 1106 canbe used. Connecting structure 1106 can be coupled to anchoring device1110 positioned on upper jaw 1102 and/or anchoring device 1112positioned on lower jaw 1104. Apparatus 1100 is configured such that oneor more connecting structures can be coupled to any combination ofanchoring devices 1108, 1110 and 1112 and/or attachment element 1116 inorder to achieve different desired displacements of lower jaw 1104relative to upper jaw 1102 during different treatment phases.

In some embodiments, the anchoring devices can include a dental implant(e.g., a prosthesis such as a crown or bridge) positioned in the upperjaw or the lower jaw of the patient and the one or more connectingstructures can include a connecting structure removably coupled to thedental implant. Because the dental implant, unlike a natural tooth, isnot coupled to a periodontal ligament, application of force to thedental implant by a connecting structure is not expected to causerepositioning or displacement of the implant. By using preexistinganchoring devices already in the patient's intraoral cavity such as adental implant, this approach can advantageously reduce the number ofnew anchoring devices that need to be placed.

The methods and apparatus provided herein can include applying more thanone force system during more than one treatment phase to achievedifferent planned and/or desired displacements of the lower jaw relativeto the upper jaw. The different displacements can be, for instance,different amounts of jaw displacement, different directions of jawdisplacement, or combinations thereof. Different force systems can beused to produce the different displacements. For example, in someembodiments, a first force system is applied during a first treatmentphase to displace the lower jaw anteriorly relative to the upper jaw,and a second force system is applied during a second treatment phase todisplace the lower jaw posteriorly relative to the upper jaw. Thedifferent force systems can be achieved by using different arrangementsand/or combinations of connecting structures coupled to anchoringdevices as described herein. In some embodiments, a first one or moreconnecting structures are removably coupled to a first subset of aplurality of anchoring devices during the first treatment phase so as toapply the first force system to the upper and lower jaws, and a secondone or more connecting structures are removably coupled to a secondsubset of the plurality of anchoring devices during the second treatmentphase so as to apply the second force system to the upper and lowerjaws.

The different force systems can be applied using the same or differentconnecting structures removably coupled to the same or differentanchoring devices. For example, the first and second subsets ofanchoring devices can be the same or different, and the first and secondone or more connecting structures can be the same or different.Different force systems can be applied, e.g., via the same connectingstructures removably coupled to different anchoring devices at differenttreatment phases, and/or via different connecting structures removablycoupled to the same anchoring devices at different treatment phases,and/or via different connecting structures removably coupled todifferent anchoring devices at different treatment phases.

In some embodiments, the methods and apparatus provide for treating apatient via both mandibular advancement and mandibular retraction.Mandibular advancement (displacing the lower jaw anteriorly relative tothe upper jaw) can be achieved by a first force system during a firsttreatment phase performed when the patient is asleep to minimize oreliminate obstruction of the airway to prevent or minimize the risk ofsleep apnea and/or snoring. Mandibular retraction (displacing the lowerjaw posteriorly relative to the upper jaw) can be achieved by a secondforce system during a second treatment phase performed when the patientis awake, and can serve, e.g., to correct a malocclusion, such as aclass III malocclusion or any other malocclusion. For class IIIpatients, the orthodontic movement can be opposite to that desired fortreating sleep apnea. In this case, the connecting structures can bearranged to treat sleep apnea at night and the class III conditionduring the day, e.g., by swapping which anchoring devices are used withthe connecting structures (e.g., elastic or stiff connectingstructures).

Similarly, the tendency of existing sleep apnea treatments to proclinethe anterior teeth could be prevented by using different alignerfeatures for day vs. night, optionally including different anchoringarrangements.

Systems, devices, methods and apparatus of the present disclosurecomprise apparatus that can be configured to achieve different jawdisplacements during different phases of treatments. For example, insome embodiments, an apparatus is configured to achieve an anteriordisplacement of the lower jaw relative to the upper jaw for treatment ofsleep apnea during a night/sleeping treatment phase and to achieve aposterior displacement of the lower jaw relative to the upper jaw fortreatment of class I and/or class III malocclusions during a day/wakingtreatment phases. FIGS. 12A and 12B show how an exemplary oral apparatuscan be reversibly configured to selectively treat apnea and/or class Ior III malocclusions during distinct treatment phases. The apparatus caninclude a connecting structure that can be installed over bone anchoringdevices positioned to advance the lower jaw to treat apnea, as shown inFIG. 12A, or over other bone anchoring devices positioned to retract thelower jaw to treat orthodontic occlusions as shown in FIG. 12B.Alternating mandibular advancement and retraction as depicted in FIGS.12A and 12B can be beneficial, for example, when treating growingpatients for sleep apnea without producing changes in thetemporomandibular joint (TMJ) that could produce class III malocclusion.Optionally, the apparatus can be used in combination with anotherorthodontic appliance, such as the tooth repositioning alignersdescribed herein. In such embodiments, at least one portion of theconnecting structure can be coupled to the appliance, e.g., as describedherein with respect to FIG. 11.

FIG. 12A depicts apparatus configuration 1200, for displacing the lowerjaw anteriorly relative to the upper jaw during a first treatment phase.In use, elastic connecting structure 1214 is removably coupled toanchoring device 1208 positioned on upper jaw 1202, and is removablycoupled to anchoring device 1210 positioned on lower jaw 1204. Anchoringdevice 1208 is positioned anteriorly relative to anchoring device 1210such that a tension in elastic connecting structure 1214 applies ananterior force 1222 to cause anterior displacement (advancement) oflower jaw 1204. Similarly, an equal and opposite posterior force 1216 isapplied to upper jaw 1202 by elastic connecting structure 1214. Tensionin elastic connecting structure 1214 also applies downward verticalforce 1218 that can cause downward vertical displacement of upper jaw1202, and upward vertical force 1220 that can cause upward verticaldisplacement of lower jaw 1204. In other embodiments of the presentdisclosure, these vertical displacements are restricted, e.g., by theuse of one or more stiff connecting structures, application of one ormore moments, or combinations thereof.

FIG. 12B depicts apparatus configuration 1250, for displacing the lowerjaw posteriorly relative to the upper jaw during a second treatmentphase. Elastic connecting structure 1214 is removably coupled toanchoring device 1206 positioned on upper jaw 1202, and is removablycoupled to anchoring device 1212 positioned on lower jaw 1204. Anchoringdevice 1206 is positioned posteriorly relative to anchoring device 1212such that a tension in elastic connecting structure 1214 applies aposterior force 1256 to cause posterior displacement (retraction) oflower jaw 1204. Similarly, an equal and opposite anterior force 1252 isapplied to upper jaw 1202 by elastic connecting structure 1214. Tensionin elastic connecting structure 1214 also applies downward verticalforce 1254 that can cause downward vertical displacement of upper jaw1202, and upward vertical force 1258 that can cause upward verticaldisplacement of lower jaw 1204. In other embodiments of the presentdisclosure, these vertical displacements are restricted, e.g. by the useof one or more stiff connecting structures, application of one or moremoments, or combinations thereof.

Systems, devices, methods and apparatus of the present disclosurecomprise embodiments that can be digitally designed. In someembodiments, apparatus of the present disclosure are designed and/orfabricated based on digital representations of the patient's teeth andjaws. Computer-based approaches such as computer modeling techniques canbe used to determine and/or predict forces and/or moments that will beapplied to teeth and/or jaws by apparatus described herein, and/orcomponents thereof (e.g., connecting structures and/or anchoringdevices). Computer-based approaches such as computer modeling techniquescan also be used to determine and/or predict forces and/or moments thatwill be applied to the apparatus described herein, and/or componentsthereof, by teeth and/or jaws.

The geometry and arrangement of the connecting structures and/oranchoring devices described herein can also be digitally designed. Insome aspects, one or more representations of the patient's teeth and/orjaws are provided, along with a desired or planned displacement of thelower jaw relative to the upper jaw, as inputs to one or morecomputer-based models. The one or more computer-based models candetermine, based on these inputs, the geometry and/or arrangement of theapparatus and/or components thereof, and/or materials or physicalproperties (e.g. elastic modulus) of the components thereof, so as toapply a force system suitable to achieve one or more desireddisplacements of the lower jaw relative to the upper jaw in accordancewith one or more treatment phases.

The various techniques described herein may be partially or fullyimplemented using code that is storable upon storage media and computerreadable media, and executable by one or more processors of a computersystem. The processor can comprise array logic such as programmablearray logic (hereinafter PAL), configured to perform the techniquesdescribed herein. Storage media and computer readable media forcontaining code, or portions of code, can include any appropriate mediaknown or used in the art, including storage media and communicationmedia, such as but not limited to volatile and non-volatile, removableand non-removable media implemented in any method or technology forstorage and/or transmission of information such as computer readableinstructions, data structures, program modules, or other data, includingRAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM,digital versatile disk (DVD) or other optical storage, magneticcassettes, magnetic tape, magnetic disk storage or other magneticstorage devices, or any other medium which can be used to store thedesired information and which can be accessed by the a system device.Based on the disclosure and teachings provided herein, a person ofordinary skill in the art will appreciate other ways and/or methods toimplement the various embodiments.

Unless otherwise defined, all technical terms used herein have the samemeaning as commonly understood by one of ordinary skill in the art towhich this invention belongs. As used in this specification and theappended claims, the singular forms “a,” “an,” and “the” include pluralreferences unless the context clearly dictates otherwise. Any referenceto “or” herein is intended to encompass “and/or” unless otherwisestated.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. Numerous differentcombinations of embodiments described herein are possible, and suchcombinations are considered part of the present disclosure. In addition,all features discussed in connection with any one embodiment herein canbe readily adapted for use in other embodiments herein. It is intendedthat the following claims define the scope of the invention and thatmethods and structures within the scope of these claims and theirequivalents be covered thereby.

What is claimed is:
 1. An apparatus for treating a patient viamandibular advancement or retraction, the apparatus comprising: aplurality of anchoring devices positioned in the patient's intraoralcavity, wherein each of the plurality of anchoring devices is positionedin bone of the patient's upper jaw or bone of the patient's lower jaw;and one or more connecting structures removably coupled to and extendingbetween the plurality of anchoring devices in order to displace thelower jaw anteriorly or posteriorly relative to the upper jaw.